Category Archives: Events

08Jul/19
Jumping

Webinar: Digital Transformation Enables Review by Exception at FDI – A Case Study

A Straight from the Source Webinar

Review by Exception is the ultimate goal of Electronic Batch Records (EBR) and Manufacturing Execution System (MES) implementations at Life-Science organizations. Yet few industry companies have achieved this goal.

Fujirebio Diagnostics Inc., (FDI) is undergoing Digital Transformation, starting with MES / EBR implementation, resulting in a Review by Exception approach for manufacturing batch records.

Join FDI’s Samantha Schloth and Axendia’s Daniel R. Matlis for a live webinar on August 6 at 11:00 AM ET to learn how Digital Transformation is enabling Review by Exception and reducing manufacturing cycle times.

We will discuss:

  • Undergoing Digital Transformation
  • Leveraging FDA’s Risk Based Computer System Assurance Approach
  • An Implementation Strategy for success
  • Moving from Paper to Digital Records
  • The Value of Review by Exception
  • Lessons learned, challenges and opportunities

Meet Your Trusted Sources

Sam Dan 3

Can’t attend the live webinar? Register to receive a link to the on-demand recording after the event.

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01Jul/19
liveworx2019 image

The Augmented Workforce – Taking Human Capabilities to New Heights

PTC 2019 LiveWorx Event Brief

By: Eric M. Luyer, Industry Research Analyst

The theme at PTC LiveWorx this year was: “The Augmented Workforce – Taking Human Capabilities to New Heights.”  Approximately 13,000 people, attending in person as well as live streaming, took part in the annual industry conference held in Boston, MA, in early June.

In today’s digital enterprise, the objective of PTC is not only unlocking new levels of productivity, insight and efficiency with automated processes and emerging technologies, but also to use these tools to “augment” the workforce.   PTC is predominantly positioning emerging technologies such as Artificial Intelligence (AI), Augmented Reality (AR), Virtual Reality (VR) and 3D Printing.  When added to the existing capabilities of Computer Aided Design (CAD), Product Lifecycle Management (PLM) and the Internet of Things (IoT), AR will become more complementary to workers’ creativity and labor satisfaction.  It is PTC’s premise that things that make us all uniquely human – intuition, creativity, decision making – will be more powerful and useful than ever, if we optimize the use of these emerging technologies.

Digital Transformation

The emphasis of LiveWorx was helping industries with their Digital Transformation strategy and approach.  PTC sees AR as an ideal tool for training.  Workers benefit by getting a 3D- understanding of production processes and the challenges in a production environment (where the shortage of skills is often a challenge – yet shorter lead-times are expected.)

PTC AR PhotoImplementing an “Augmented Workforce” as part of the digital transformation process requires new strategies, a strategic roadmap and bold experimentation – as well as a culture ready to embrace change.

The use of AR makes a workforce more complete, rather than being replaced by it – where workers and machines unite to make and manage what’s next.  In her keynote address, Maria Wilson DDA, of Howden Group noted, “Augmented reality extends the value of our IoT data, and it changes our customers’ experience of owning and operating equipment.”

The Digital Thread

Jim Heppelmann, CEO of PTC, emphasized the importance of having the technology and the tools available to have full insight of what’s happening in the product lifecycle:  from design – engineering – manufacturing & supply chain – customer operations – customer services to Corporate/CXO.  In his keynote, Heppelmann explained the capabilities of the current PTC offerings for manufacturers:  from complex configuration management to high performance computing, including how CAD + PLM + IoT + AI follow and support the concept of the Digital Thread.

Jim Heppelmann, CEO at PTC. Image Courtesy of PTC.

Jim Heppelmann, CEO at PTC. Image Courtesy of PTC.

According to Heppelmann, “A digital thread means the information that was originally created for one purpose – say an engineering prototype – gets reused for many different processes.  The digital thread weaves its way across the value chain. ” The digital thread is in fact a framework which connects the data flows to provide a holistic view of all data of (all) assets and the processes linked to these during the lifecycle of the product. All information including protocols, security and standards are visible and transparent.

The concept of the digital thread describes the traceability of the data that supports the digital twin(s) back to requirements (i.e., design phase), parts and controls that can make up the physical asset(s) or the entire production process.

Life-Sciences and The Future of Medical Innovation

The Life Science industry is in a state of transition at many levels, with new market entrants (e.g. Google and Amazon) and a wave of mergers and acquisitions shaking up the competitive landscape.  Now more than ever, medical innovators face an increasing need for technology solutions to support the transition to connected healthcare, personalized and precision medicine, and improved patient outcomes as a service — all while ensuring compliance with regulatory requirements.

PTC’s portfolio and expertise aims to help medical device manufacturers gain a competitive advantage in a complex, fast paced and highly regulated marketplace. With targeted focus on quality in the design phase, combining Additive Manufacturing (3D printing) capabilities (specifically AR and VR in support of quality for design, services and training) PTC is offering its Life Science clients well-thought-out, and high-performing technology solutions that can grow with the increasing complexity of quality and regulatory requirements.

Life Science innovators face transformative opportunities and challenges. The health-care value chain is becoming more collaborative, outcome-based and metrics-driven. Precision medicine, additive manufacturing, and connected medical products are rapidly expanding the art of the possible. For medical innovators and the healthcare communities they serve, the future is bright in the eyes of PTC’s solutions development group.

Cybersecurity

In this new digital world, cyber safety and security must become everyone’s responsibility, and work must be done to address the challenges and threats around safety and security. “Sophisticated software and hyper-connectivity are fuelling innovation at an unprecedented pace,” said Joshua Corman, SVP and Chief Security Officer, of PTC. “Those conditions can potentially introduce new classes of accidents and adversaries,” added Corman.   PTC has subsequently initiated a Coordinated Vulnerability Disclosure (CVD) Program that supports the reporting and remediation of security vulnerabilities that could potentially affect the environments in which PTC products operate, including industrial and safety-critical industries.

Announcements: Featured Partnerships

At LiveWorx 2019, strategic partnerships were on display.  First, Rockwell Automation.  This partnership is expected to accelerate growth for both companies and enable them to be the partner of choice for customers who want to transform their physical operations with digital technology. “Leveraging Rockwell Automation’s industry-leading industrial control and software technology, strong brand, and domain expertise with PTC’s award-winning technology, enables industrial enterprises to capitalize on the promise of the Industrial IoT. I am incredibly excited about this partnership and the opportunity it provides to fuel our future success,” said Jim Heppelmann, CEO of PTC.

Secondly, PTC’s partnership with Microsoft.  On June 10th, PTC announced that it has expanded its strategic alliance with Microsoft by delivering its industry-leading PLM solution Windchill on Microsoft Azure. Optimizing Windchill with Azure is yet another milestone in the growing alliance between the two companies since the initial announcement in 2018. PTC and Microsoft have closely collaborated on integrating Azure IoT with PTC’s IIoT solution platform, which has allowed customers to create innovative products and improve operations with IoT connectivity, rich contextualization, business systems orchestration, and breakthrough user engagement via mixed reality.

liveworx2019 image

In conclusion, LiveWorx 2019 was an interesting and forward-thinking conference this year…especially for organizations that are either starting or are already on their journey of digitally transforming their key business processes.

Download a PDF of this Event Brief.

 

26Jun/19
Digital Evidence Webinar

FDA Discusses the Use of Digital Evidence to Accelerate Innovation

A Straight from the Source Webinar

FDA is encouraging the use of “Digital Evidence to accelerate product innovation supporting rapid introduction of life-saving technology for patients “Digital evidence” is already being used at FDA to predict clinical outcomes, inform clinical trial design, support demonstration of safety and effectiveness, identify relevant patient populations, and support regulatory submissions. 

Join FDA’s Tina M. Morrison and Axendia’s Daniel R. Matlis for a live webinar on July 10 at 11:00 AM ET. 

We will discuss FDA’s perspective on: 

  • Shifting from traditional evidence sources to digital and real world evidence  
  • Modeling and Simulation to support improved quality and patient outcomes 
  • Examples of Digital Evidence currently in use at FDA 
  • The Review of the Futureharnessing the power digital and real world evidence through digital transformation 

Meet Your Trusted Sources

Tina and Dan for CC

Over 200 FDA employees are part of the Agency’s Modeling and Simulation working group. Find out what they are working on and more.  

Scheduling Conflict? Register and receive a link to view the on-demand recording after the event.

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21May/19
IoPP Logo

Puerto Rico Packaging Summit 2019

Event Brief

By: Sandra K. Rodriguez, Market Analyst

The Puerto Rico Packaging Summit 2019 took place in Condado, Puerto Rico.  The summit focused on the Institute of Packaging Professionals (IoPP) – Puerto Rico Chapter’s core organizational value: Packaging Contribution.  The Summit drew 129 attendees, representing 48 companies.

The message was simple and clear: We Speak Packaging. Speak Packaging With Us.

IoPP PresentersToday, advanced technologies including deep learning, artificial intelligence and robotics are playing a key role in an important piece of the supply chain and manufacturing processes.  Presentations by Amgen, Adents, Rockwell Automation, Pfizer and Hi-Tech Products demonstrated not if or when, but how automation and technology is already impacting manufacturing and operations in the Life-Sciences.

Jorge Delgado, Sr. Manager of Process Development at Amgen explained that deep learning can help overcome some challenges in Automatic Visual Inspection (AVI).  “Even with multiple techniques, it is still a challenge to effectively detect particles using current AVI technologies for particle detection,” said Delgado. Continue reading

01May/19
Living-heart-project

Axendia to Provide Life-Science Analyst Keynote at 3DEXPERIENCE FORUM 2019

Harnessing Positive Disruption in Life Sciences to Achieve Patient-Centric Care

By: Daniel R. Matlis, President

Life-Science organizations must transform or be disrupted! They must harness positive disruption to achieve patient-centric care that supports prevention, improves outcomes as well as providing a holistic patient experience that drives value.

However, to achieve patient-centric care, Life-Science organizations must undergo digital transformation that enables closed loop visibility across the product lifecycle. This transformation requires core paradigm shifts in corporate culture, incentives, strategic planning, regulatory frameworks as well as technological solutions for industry stakeholders.

Male-Anatomy-Background-composite-cropped-low-resNew technologies like modeling and simulation, artificial intelligence and the Internet of Medical Things (IoMT) are enabling patient-centric models to serve more people around the world. The foundation of patient-centric care is the ability to connect the real and digital worlds through multi-discipline, multi-scale modeling and simulation, IoMT connected devices, visibility to data for decision support and greater collaboration. Continue reading